Lung CancerPhase 2NCT01553942
Afatinib With CT and RT for EGFR-Mutant NSCLC
A Phase 2 study testing Afatinib, Radiation and Cisplatin in people with Lung Cancer, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Afatinib, Radiation and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2012to Dec 2024
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed stage IIIA NSCLC
- Measurable disease
- Have lung cancer harboring an EGFR mutation
- Must be evaluated by a medical oncologist, radiation oncologist and thoracic surgeon within 4 weeks of enrollment into study to document that they are a candidate for chemoradiation and for consideration of surgical resection (not required to be a surgical candidate)
Who cannot join
- Pregnant or breastfeeding
- Prior EGFR TKI therapy
- Prior treatment with radiation to the thoracic region (including breast irradiation)
- Known pre-existing interstitial lung disease
- Significant or recent gastrointestinal disorders with diarrhea as a major symptom
- History or presence of relevant cardiovascular abnormalities
Show all 12Show fewer
- Any other concomitant serious illness or organ system dysfunction
- Active hepatitis B, C or known HIV carrier
- Known or suspected active drug or alcohol use
- Known hypersensitivity to afatinib, cisplatin, or pemetrexed
- Concomitant treatment with strong inhibitor of P-gp
- History of an active malignancy within the last 3 years
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Massachusetts General Hospital
Boston, Massachusetts, 02215
About this study
Official title: Afatinib Sequenced With Concurrent Chemotherapy and Radiation in EGFR-Mutant Non-Small Cell Lung Tumors: The ASCENT Trial
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that study doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not yet approved the drug for the patients type of cancer or for any use outside of research studies.
Chemotherapy and radiation is the standard treatment for the patients with stage III non-small cell lung cancer (NSCLC). For people with epidermal growth factor receptor (EGFR) mutations, adding a type of drug called a tyrosine kinase inhibitor (TKI) can help increase the response to treatment.
Read more
Afatinib is a tyrosine kinase inhibitor. It has been studied in a previous research study in participants with more advanced NSCLC. Results from that study indicate it may be helpful in treating NSCLC with EGFR mutations.
In this study, patients with stage III NSCLC and EGFR mutations will receive the standard treatment of radiation and chemotherapy. If possible, the patients tumor will be removed by surgery. Afatinib will be given before radiation and chemotherapy and after surgery. The aim of giving afatinib before radiation therapy is to try to shrink the tumor. This may make the radiation therapy more effective since radiation therapy tends to work better on smaller tumors.
The goal of this study is to see if adding afatinib to standard treatment helps to improve the response to treatment.
Read the detailed description
Study treatment will be divided into 5 stages:
Stage 1-induction, consisting of afatinib for two 4-week cycles. Afatinib is a pill that the patient takes by mouth once per day. The patient will receive a study drug diary in which to record the doses of afatinib.
Stage 2-concurrent radiation and chemotherapy with cisplatin/pemetrexed for two 3-week cycles.
Stage 3-Surgery to remove tumor for participants whose tumor can be removed by surgery. This will be done about 4-6 weeks after finishing radiation and chemotherapy. The exact timing will depend upon how quickly the patient recovers from side effects of the radiation and chemotherapy. The investigators will use a piece of the patients tumor removed by surgery for research tests to look for biomarkers such as genes and proteins that may be associated with response to afatinib, chemotherapy or radiation.
Stage 4-Chemotherapy after surgery (adjuvant chemotherapy). The patients doctor will decide if the patient will receive chemotherapy after the patients surgery but before receiving consolidation with afatinib. If the patient does receive this, it will start 6-12 weeks after surgery or finishing radiation if the patient does not have surgery. The chemotherapy will be the same as that received along with the radiation therapy.
Stage 5-Consolidation with afatinib for twenty-six 4-week cycles (2 years) for participants who responded to the 2 cycles of induction afatinib.
The investigators would like to keep track of the patients medical condition and status of the patients disease for up to 5 years after the patient stops study treatment. Keeping in touch with the patients and checking on the patients condition every year helps the investigators look at the long-term effects of the research study. The patients will be asked to have CT scans as follows:
- Every 3 months for the first year after stopping study treatment
- Every 6 months for years 2-4 after stopping study treatment
- Once per year in year 5 after stopping study treatment
- Conditions
- Lung Cancer
- Being tested
- Afatinib, Radiation, Cisplatin, Pemetrexed, Surgery
- Keywords
- NSCLC
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfatinibDrug
induction phase-two 4 week cycles. consolidation phase-twenty six 4 week cycles
RadiationRadiation
Daily, Monday-Friday
CisplatinDrug
Day 1 of each cycle, IV infusion over 60 minutes
PemetrexedDrug
Day 1 of each cycle, given as IV infusion over 10 minutes after cisplatin infusion
SurgeryProcedure or surgery
Surgery to remove tumor
| Study group | Role | What they receive |
|---|---|---|
| Afatinib | Experimental | Afatinib Receives: Drug: Afatinib; Radiation: Radiation; Drug: Cisplatin; Drug: Pemetrexed; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
Assess the response rate to induction afatinib.
Measured: 2 years
Secondary outcomes (5)
2 Year Progression-Free Survival
Estimate the 2-year progression-free survival (PFS)
Measured: 2 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Describe the number of patients that have side effects of various types from the study treatment
Measured: 2 years
Unresectable Disease Converted to Operable Cases
Estimate the proportion of patients with initially unresectable disease that can be converted to operable cases
Measured: 2 years
Locoregional Tumor Control Rates
Estimate 2-year locoregional tumor control rates, distant metastasis rates and overall survival rates, as well as median overall survival (OS)
Measured: 2 years
Evaluation of EGFR Mutation Status and other genotypes
Evaluate the status of various relevant genes such as EGFR, MET, and other genes that might be related to response or resistance to afatinib, and assess relationship to clinical outcomes
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lecia V. Sequist, Massachusetts General Hospital
- Investigators
- Lecia V Sequist, MD MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553942
- Sponsor's protocol ID
- 11-464
- Status last verified
- Nov 2024
- First submitted
- 5 Mar 2012
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Afatinib Sequenced With Concurrent Chemotherapy and Radiation in EGFR-Mutant Non-Small Cell Lung Tumors: The ASCENT Trial
- ClinicalTrials.gov ID
- NCT01553942
- Acronym / sponsor ID
- 11-464
- Conditions
- Lung Cancer
- Keywords
- NSCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that the drug is still being studied and that study doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not yet approved the drug for the patients type of cancer or for any use outside of research studies.
Chemotherapy and radiation is the standard treatment for the patients with stage III non-small cell lung cancer (NSCLC). For people with epidermal growth factor receptor (EGFR) mutations, adding a type of drug called a tyrosine kinase inhibitor (TKI) can help increase the response to treatment.
Afatinib is a tyrosine kinase inhibitor. It has been studied in a previous research study in participants with more advanced NSCLC. Results from that study indicate it may be helpful in treating NSCLC with EGFR mutations.
In this study, patients with stage III NSCLC and EGFR mutations will receive the standard treatment of radiation and chemotherapy. If possible, the patients tumor will be removed by surgery. Afatinib will be given before radiation and chemotherapy and after surgery. The aim of giving afatinib before radiation therapy is to try to shrink the tumor. This may make the radiation therapy more effective since radiation therapy tends to work better on smaller tumors.
The goal of this study is to see if adding afatinib to standard treatment helps to improve the response to treatment.
Detailed description
Study treatment will be divided into 5 stages:
Stage 1-induction, consisting of afatinib for two 4-week cycles. Afatinib is a pill that the patient takes by mouth once per day. The patient will receive a study drug diary in which to record the doses of afatinib.
Stage 2-concurrent radiation and chemotherapy with cisplatin/pemetrexed for two 3-week cycles.
Stage 3-Surgery to remove tumor for participants whose tumor can be removed by surgery. This will be done about 4-6 weeks after finishing radiation and chemotherapy. The exact timing will depend upon how quickly the patient recovers from side effects of the radiation and chemotherapy. The investigators will use a piece of the patients tumor removed by surgery for research tests to look for biomarkers such as genes and proteins that may be associated with response to afatinib, chemotherapy or radiation.
Stage 4-Chemotherapy after surgery (adjuvant chemotherapy). The patients doctor will decide if the patient will receive chemotherapy after the patients surgery but before receiving consolidation with afatinib. If the patient does receive this, it will start 6-12 weeks after surgery or finishing radiation if the patient does not have surgery. The chemotherapy will be the same as that received along with the radiation therapy.
Stage 5-Consolidation with afatinib for twenty-six 4-week cycles (2 years) for participants who responded to the 2 cycles of induction afatinib.
The investigators would like to keep track of the patients medical condition and status of the patients disease for up to 5 years after the patient stops study treatment. Keeping in touch with the patients and checking on the patients condition every year helps the investigators look at the long-term effects of the research study. The patients will be asked to have CT scans as follows:
- Every 3 months for the first year after stopping study treatment
- Every 6 months for years 2-4 after stopping study treatment
- Once per year in year 5 after stopping study treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Afatinib | Experimental | Drug: Afatinib, Radiation: Radiation, Drug: Cisplatin, Drug: Pemetrexed, Procedure: SurgeryAfatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed stage IIIA NSCLC
- Measurable disease
- Have lung cancer harboring an EGFR mutation
- Must be evaluated by a medical oncologist, radiation oncologist and thoracic surgeon within 4 weeks of enrollment into study to document that they are a candidate for chemoradiation and for consideration of surgical resection (not required to be a surgical candidate)
Key exclusion criteria (12 listed)
- Pregnant or breastfeeding
- Prior EGFR TKI therapy
- Prior treatment with radiation to the thoracic region (including breast irradiation)
- Known pre-existing interstitial lung disease
- Significant or recent gastrointestinal disorders with diarrhea as a major symptom
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Afatinibinduction phase-two 4 week cycles. consolidation phase-twenty six 4 week cycles | Drug | Afatinib |
| RadiationDaily, Monday-Friday | Radiation | Afatinib |
| CisplatinDay 1 of each cycle, IV infusion over 60 minutes | Drug | Afatinib |
| PemetrexedDay 1 of each cycle, given as IV infusion over 10 minutes after cisplatin infusion | Drug | Afatinib |
| SurgerySurgery to remove tumor | Procedure or surgery | Afatinib |
Primary outcome
Response Rate
Time frame: 2 years
Assess the response rate to induction afatinib.
5 secondary outcomes
2 Year Progression-Free Survival
Time frame: 2 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 2 years
Unresectable Disease Converted to Operable Cases
Time frame: 2 years
Locoregional Tumor Control Rates
Time frame: 2 years
Evaluation of EGFR Mutation Status and other genotypes
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lecia V Sequist, MD MPH principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Afatinib, Radiation and Cisplatin in people with Lung Cancer, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.